One-year outcomes of the treat-and-extend regimen using aflibercept for the treatment of diabetic macular edema

Abstract Purpose: To investigate longer-term functional and morphological outcomes and their predictors in diabetic macular edema (DME) following a treat and extend regimen (TER) without loading dose under ranibizumab. Methods: Patient data were reviewed and analyzed retrospectively over a period of 24 months after initiation of TER. Best-corrected visual acuity (BCVA), treatment frequency as well as quantitative and qualitative Spectral-domain Optical Coherence Tomography parameters were assessed. Results: 118 eyes of 87 patients were included. A mean of 9.742.13 injections in the first and 7.632.29 in the second year were applied. There were significant gains of BCVA and reductions in central retinal thickness from baseline to month 12 and 24 (all p<0.001). Percentage of eyes with an intact inner-/outer segment (IS/OS) junction increased from 15.3% at baseline to 42.1% at month 24 (p<0.001). An intact IS/OS junction at baseline increased the probability of having a dry retina after 12 months by 79.3% (p=0.017) and after 24 months by 88.1% (p=0.040). Less IS/OS disruption at baseline predicted longer maximum recurrence-free treatment intervals at 2 years (r=-0.345, p<0.001) and better BCVA at one year (r=-0.347, p<0.001). Baseline bigger intraretinal cysts were associated with more IS/OS disruption at 24 months (r=0.305, p=0.007). Younger age and lower BCVA at baseline were predictive for a higher BCVA gain at 24 months (p=0.046, p<0.001). Conclusion: Ranibizumab applied in a TER without loading dose in DME significantly improves visual acuity and retinal anatomical structure throughout two years. The evaluated predictors might help to guide routine clinical treatment in DME.

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One-Year Results of Using a Treat-and-Extend Regimen without a Loading Phase with Anti-VEGF Agents in Patients with Treatment-Naive Diabetic Macular Edema

Ophthalmologica ◽

10.1159/000495623 ◽

2019 ◽

Vol 241 (4) ◽

pp. 220-225 ◽

Cited By ~ 7

Author(s):

Petra Schwarzer ◽

Andreas Ebneter ◽

Marion Munk ◽

Sebastian Wolf ◽

Martin S. Zinkernagel

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Treat And Extend ◽

Anti Vegf ◽

Treatment Naïve ◽

One Year ◽

Treat And Extend Regimen

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Comparison of outcomes between intravitreal ranibizumab and intravitreal aflibercept for diabetic macular edema with “Treat-and-Extend” regimen

10.21203/rs.2.21161/v1 ◽

2020 ◽

Author(s):

Masahiko Sugimoto ◽

Shinichiro Chujo ◽

Taku Sasaki ◽

Atsushi Ichio ◽

Ryohei Miyata ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Retinal Thickness ◽

Intravitreal Ranibizumab ◽

Treat And Extend ◽

Corrected Visual Acuity ◽

Anti Vegf ◽

Intravitreal Aflibercept ◽

Treatment Naïve ◽

Treat And Extend Regimen

Abstract Background To compare the effectiveness of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) performed with the Treat-and-Extend (TAE) regimen on eyes with diabetic macular edema (DME).Patients and methods This was a retrospective study of 125 eyes of 125 treatment naïve DME patients who received anti-VEGF injections at 3 consecutive monthly intervals as the loading phase. Of these 125 eyes, 26 eyes completed the treatment with the TAE regimen for at least 24 months. Among the 26 eyes, 13 eyes of 13 patients (mean age, 70.9±6.0 years) received intravitreal injections of 0.5 mg ranibizumab and 13 eyes of 13 patients (65.9±8.6 years) received 2 mg aflibercept. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity (DRS), and total injection numbers were compared between the two anti-VEGF agents.Results No significant differences were detected in the baseline demographics. At 24 months, the BCVA was significantly improved in both groups; from 0.31±0.19 to 0.10±0.12 logMAR units for IVR and 0.41±0.19 to 0.16±0.28 logMAR units for IVA ( P=1.29x10 -9 ). The CRT was significantly reduced in both groups; 440.9±69.3 to 307.5±66.4 μm for IVR and 473.9±71.5 to 317.8±71.2 μm for IVA ( P=3.55x10 -9 ). No significant differences were detected in the improvements of the BCVA and the CRT in both groups, and the total injection numbers were significant fewer for the IVA group (11.0±1.2) than the IVR group (12.0±1.0). The DRS was significantly improved in both groups ( P =0.0004 for IVR and P =0.009 for IVA).Conclusion No significant differences were detected in the improvements of the BCVA or CRT and injection numbers between IVR and IVA groups treated with the TAE regimen. These results indicate that the results of the treatment with both agents with the TAE regimen were equally effective.

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Clinical Outcomes of a Treat and Extend Regimen with Intravitreal Aflibercept Injections in Patients with Diabetic Macular Edema: Experience in Clinical Practice

Ophthalmology and Therapy ◽

10.1007/s40123-019-00224-x ◽

2019 ◽

Vol 9 (1) ◽

pp. 87-101 ◽

Cited By ~ 4

Author(s):

Beverley A. Curry ◽

Paul G. Sanfilippo ◽

Sarah Chan ◽

Alexander W. Hewitt ◽

Nitin Verma

Keyword(s):

Clinical Practice ◽

Macular Edema ◽

Clinical Outcomes ◽

Diabetic Macular Edema ◽

Treat And Extend ◽

Intravitreal Aflibercept ◽

Treat And Extend Regimen

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One-Year Results of Treatment of Diabetic Macular Edema with Aflibercept Using the Treat-and-Extend Dosing Regimen: the VIBIM Study

Ophthalmologica ◽

10.1159/000504753 ◽

2020 ◽

Vol 243 (4) ◽

pp. 255-262

Author(s):

Kang Yeun Pak ◽

Jae Pil Shin ◽

Hyun Woong Kim ◽

Min Sagong ◽

Yu Cheol Kim ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Dosing Regimen ◽

Treat And Extend ◽

Results Of Treatment ◽

One Year

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Comparison of outcomes between intravitreal ranibizumab and intravitreal aflibercept for diabetic macular edema with “Treat-and-Extend” regimen

10.21203/rs.2.16775/v1 ◽

2019 ◽

Author(s):

Masahiko Sugimoto ◽

Shinichiro Chujo ◽

Taku Sasaki ◽

Atsushi Ichio ◽

Ryohei Miyata ◽

...

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Intravitreal Ranibizumab ◽

Treat And Extend ◽

Corrected Visual Acuity ◽

Intravitreal Aflibercept ◽

Number Of Injections ◽

Best Corrected Visual Acuity ◽

Treat And Extend Regimen

Abstract Background To compare the effectiveness of intravitreal ranibizumab (IVR) and aflibercept (IVA) with the Treat-and-Extend (TAE) regimen for diabetic macular edema (DME).Patients and methods Thirteen eyes received an intravitreal injection of 0.5 mg ranibizumab (mean age, 70.9±6.0 years) and 13 eyes received 2 mg aflibercept (65.9±8.6 years). After 3 consecutive monthly injections, they received additional injections with the TAE regimen. The changes in the best-corrected visual acuity (BCVA), CRT, and total number of injections were compared.Results No significant differences were detected in the baseline demographics. The BCVA was significantly improved for both groups; 0.31±0.19 to 0.10±0.12 logMAR units for IVR and 0.41±0.19 to 0.16±0.28 logMAR units for IVA at 24 months ( P <0.01). The CRT was significantly reduced in both groups; 440.9±69.3 to 307.5±66.4 μm for IVR and 473.9±71.5 to 317.8±71.2 μm for IVA at 24 months ( P <0.01). No significant differences were detected in the improvements of the BCVA and reduction in the CRT between them. The total number injections were significant fewer for the IVA group (11.0±1.2) than the IVR group (12.0±1.0) at 24 months ( P =0.02).Conclusion The results showed that the TAE regimen was effective. The IVA group required fewer injections to attain the same improvements.

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Prospective Clinical Trial of Intravitreal Aflibercept Treat-and-extend Regimen for Diabetic Macular Edema: 1-Year Outcomes

Korean Journal of Ophthalmology ◽

10.3341/kjo.2020.0003 ◽

2020 ◽

Vol 34 (4) ◽

pp. 290

Author(s):

Hiroki Mieno ◽

Kazuhito Yoneda ◽

Nobuhiro Terao ◽

Kengo Yoshii ◽

Kentaro Kojima ◽

...

Keyword(s):

Clinical Trial ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Prospective Clinical Trial ◽

Treat And Extend ◽

Intravitreal Aflibercept ◽

Treat And Extend Regimen

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Comparison of 2-Year Outcomes between Intravitreal Ranibizumab and Intravitreal Aflibercept for Diabetic Macular Edema with “Treat-and-Extend” Regimen—Its Usefulness and Problems

Journal of Clinical Medicine ◽

10.3390/jcm9092848 ◽

2020 ◽

Vol 9 (9) ◽

pp. 2848

Author(s):

Shinichiro Chujo ◽

Masahiko Sugimoto ◽

Taku Sasaki ◽

Yoshitsugu Matsui ◽

Kumiko Kato ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Continuous Treatment ◽

Intravitreal Ranibizumab ◽

Treat And Extend ◽

Corrected Visual Acuity ◽

Anti Vegf ◽

Intravitreal Aflibercept ◽

Treatment Naïve ◽

Treat And Extend Regimen

Background: To compare the effectiveness of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) performed with the treat-and-extend (TAE) regimen on eyes with diabetic macular edema (DME). Patients and methods: This is a retrospective study of 125 eyes of 125 treatment-naïve DME patients who received anti-VEGF injections at three consecutive monthly intervals as the loading phase. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity scale (DRSS), and total injection numbers were compared between the two anti-VEGF agents. Results: Among 125 eyes, 26 eyes completed the treatment with the TAE regimen for 24 months (20.8%). Thirteen eyes of 13 patients (mean age, 70.9 ± 6.0 years) received intravitreal injections of 0.5 mg ranibizumab, and 13 eyes of 13 patients (65.9 ± 8.6 years) received 2 mg aflibercept. No significant differences were detected in the baseline demographics. At 24 months, BCVA was significantly improved in both groups; from 0.31 ± 0.19 to 0.10 ± 0.12 logMAR units for IVR and 0.41 ± 0.19 to 0.16 ± 0.28 logMAR units for IVA (p = 1.29 × 10−9). CRT was significantly reduced in both groups; 440.9 ± 69.3 to 307.5 ± 66.4 μm for IVR and 473.9 ± 71.5 to 317.8 ± 71.2 μm for IVA (p = 3.55 × 10−9). No significant differences were detected in the improvements of BCVA, CRT in both groups, and the total injection numbers for 24 months (11.0 ± 1.2 for the IVA group and 12.0 ± 1.0 the IVR group). DRSS was significantly improved in both groups (p = 0.0004 for IVR and p = 0.009 for IVA). Conclusion: No significant differences were detected in the improvements of BCVA or CRT and injection numbers between the IVR and IVA groups treated with the TAE regimen. These results indicate that the results of the treatment with both agents with the TAE regimen were equally effective, but only 20.8% of patients completed 24 months of continuous treatment with the TAE regimen. Synopsis: There are no significant differences regarding effectiveness between the IVR and IVA groups treated with the TAE regimen for DME eyes.

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